Taris Biomedical played its cards close to the vest in its early days, but it was apparently moving with great speed. The Cambridge, MA-based biotech company, a startup from the MIT labs of Michael Cima and Bob Langer, left stealth mode about six months ago and is already bounding ahead to mid-stage clinical trials.
Taris raised its first $15 million in August 2008, a story which my colleague Ryan McBride broke for us back in June. A couple weeks later, Christine Bunt, the company’s co-founder and chief operating officer, revealed at our XSITE event that the company was already designing its first clinical trials, including one for interstitial cystitis, sometimes called painful bladder syndrome. By the time I met Bunt for a follow-up interview in early November, she surprised me by saying the company had passed its first safety trial and was prepping for a Phase II study that could offer real evidence that its idea works in people.
Today, the company is formally announcing that it passed the first trial, without providing details, other than to say results will come out soon in a peer-reviewed scientific journal. But other companies that have tried similar drug-device combo treatments for the bladder have failed in their first clinical trial, which is what makes this trial noteworthy. Langer said in a statement that the initial Taris trial matters because it “validates the core platform technology.”
So what has enabled Taris to move so quickly?
“The FDA and the NIH recognize the unmet need for interstitial cystitis,” Bunt says.
What it means is there aren’t many other good treatment options for the condition Taris is targeting. An estimated 1.3 million people in the U.S.—more than 90 percent of them women—suffer from varying degrees of interstitial cystitis. Scientists don’t really know what causes the condition, and it’s hard to diagnose. But urologists and primary care doctors are all too familiar with the complaints people make about frequent urination, and pain during urination, which can be intense. In some severe cases, patients have to urinate as many as 60 times a day, according to the National Institutes of Health.
Painful and frequent urination may not sound all that serious at first, but Bunt goes out of her way to emphasize that the medical community is putting a high priority on new therapies. The suicide rate in patients with this condition is five to seven times higher than the national average, Bunt says. The NIH supports a group of researchers in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network, who are seeking to better characterize the disease, with a budget that exceeds $26 million, Bunt says.
Johnson & Johnson’s pentosan (Elmiron), an oral tablet, is one treatment option. It was cleared for sale by the FDA in 1996, but it only helps relieve symptoms for about 30 percent of patients, according to the NIH. Scientists aren’t sure how it works, although one hypothesis is that it may repair defects in the bladder lining.
Another option is basically a bladder wash, in which doctors insert a catheter up the urinary tract into the bladder, and release dimethyl sulfoxide, known as DMSO. Treatments are given every week or two for as much as two months, and repeated as needed, which isn’t ideal for a chronic disease, Bunt says. Instead of DMSO, some patients get a lidocaine cocktail, although that regimen isn’t FDA approved. Other patients simply take over-the-counter pain medications.
The Taris system, which it calls LiRIS, still requires a medical professional to perform the catheter procedure through the urinary tract, but it shouldn’t have to be done as often, Bunt says. The device, which Bunt pulled out of a business-card holder to show me
